Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Applicant’s preliminary amendment of 5 November 2025, in which claims 1-12 have been amended, is acknowledged.
Claims 1-12 are pending in the instant application.
Claims 1-12 are examined herein.
Priority
The instant application is a National Stage entry of International Application No. PCT/JP2022/004603, filed on 7 February 2022, which claims priority from Japan Patent Application 2021-017510, filed on 5 February 2021.
A certified copy of the priority document, in Japanese, has been submitted on 2 August 2023.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 2 November 2023 is acknowledged and considered.
Claim Rejections- 35 USC 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 5, 6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Makinen (Med Princ Pract 2011, 20, 303-320, cited in PTO-892).
Makinen teaches (Abstract, Figure 3, Table 3) a method of preventing dental caries with xylitol.
Makinen teaches (abstract) that xylitol is a safe and effective caries-limiting sweetener. Habitual use of xylitol-containing food, as in instant claim 6, and oral hygiene adjuvants, which are pharmaceutical products, as in instant claim 5, has been shown to reduce the growth of dental plaque, to interfere with the growth of caries-associated bacteria, to decrease the incidence of dental caries, and to be associated with remineralization of caries lesions.
Makinene teaches (Table 3) a method of reducing dental caries with xylitol in a full diet, or xylitol candies, or xylitol caramels, where xylitol is in a food product, as in instant claim 6, or with xylitol pastilles, as a pharmaceutical product, as in instant claim 5.
By teaching that xylitol is effective to prevent dental caries and protect against the growth of caries-associated bacteria, Makinen implicitly teaches that xylitol is effective to prevent tooth nerve pain/peripheral neuropathy caused by dental caries and tooth decay.
As such, claims 1, 5, 6 are anticipated by Makinen.
Claim Rejections- 35 USC 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 4, 9, 12 are rejected under 35 U.S.C. 103 as being unpatentable over Wolnerhanssen et al. (Critical Reviews in Food Science and Nutrition 2020, 60 (12), 1986-1998, published on line 16 June 2019, cited in PTO-892), in view of Obrosova (Biochimica et Biophysica Acta 2009, 1792, 931-940, cited in PTO-892).
Wolnerhanssen (Critical Reviews in Food Science and Nutrition 2020, 60 (12), 1986-1998) teaches that xylitol is effective to treat diabetes.
Wolnerhanssen teaches (Table 1) effects of xylitol on glycemic and metabolic parameters. Wolnerhanssen teaches (Table 1) that administration of 10% xylitol solution instead of water 5 weeks Type 2 diabetic rats improved glucose tolerance and increased serum insulin, reduced food and fluid intake, body weight, reduced blood glucose.
Wolnerhanssen teaches (Table 1) that various concentrations and dosages of xylitol administered to type 2 diabetic rats decreased blood glucose levels.
Wolnerhanssen teaches (page 1988, left column, first paragraph) that supplementation of a 10%- or 20%-xylitol containing diet for three weeks, dose-dependently reduced serum glucose in normal and streptozotocin-induced diabetic rats and reduced food intake and weight gain.
Thus, Wolnerhanssen teaches that xylitol, as food product, as in instant claim 12, or as a pharmaceutical product, as in instant claim 9, is effective to treat diabetes and is effective to reduce serum glucose levels in subjects with type 2 diabetes.
Wolnerhanssen teaches (Table 2) that erythritol as food product, as in instant claim 12, or as a pharmaceutical product, as in instant claim 9, is effective to treat diabetes and is effective to reduce serum glucose levels in subjects with type 2 diabetes.
Wolnerhanssen does not teach that xylitol is effective to treat diabetic peripheral neuropathy, as in the instant claims 1, 4.
Wolnerhanssen does not teach that D-threitol is effective to treat diabetes and diabetic peripheral neuropathy as complication of diabetes, as in the instant claims 1, 4.
Obrosova (Biochimica et Biophysica Acta 2009, 1792, 931-940) teaches (page 931, left column, first paragraph) that diabetic peripheral neuropathy affects at least 50% of diabetic patients. Obrosova teaches that two largest clinical trials in subjects with Type 1 and Type 2 diabetes indicate that intensive therapy and improved blood glucose control reduce incidence and slow progression of peripheral diabetic neuropathy (PDN) thus implicating hyperglycemia as a leading causative factor.
It would have been obvious for a person of ordinary skill in the art to combine the teachings of Wolnerhanssen and Obrosova to arrive at the instantly claimed invention. The person of ordinary skill in the art would have been administered xylitol, as a food product, as in instant claim 12, or as a pharmaceutical product, as in instant claim 9, to a patient suffering from diabetes, with the expectation that xylitol is effective to reduce/control blood glucose levels in the patient, and such reduction/control of blood glucose levels will reduce incidence and slow progression of peripheral diabetic nephropathy in said patient.
Further, the person of ordinary skill in the art would have been motivated to administer D-threitol in a method of treating diabetes, because Wolnerhanssen teaches that erythritol as food product, as in instant claim 12, or as a pharmaceutical product, as in instant claim 9, is effective to treat diabetes and is effective to reduce serum glucose levels in subjects with type 2 diabetes. Thus, the person of ordinary skill in the art would have administered a diastereoisomer of erythritol, namely D-threitol, to a patient suffering from diabetes, with the expectation that D-threitol is effective to treat diabetes and is effective to reduce serum glucose levels in subjects with type 2 diabetes.
In the absence of unexpected results, stereoisomers are considered obvious variants of each other. "Compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties". In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977).
Further, based on the combined teachings of Wolnerhanssen and Obrosova, the person of ordinary skill in the art would have been administered D-threitol as a food product, as in instant claim 12, or as a pharmaceutical product, as in instant claim 9, to a patient suffering from diabetes, with the expectation that D-threitol (like its diastereoisomer erythritol) is effective to reduce/control blood glucose levels in the patient, and such reduction/control of blood glucose levels will reduce incidence and slow progression of peripheral diabetic nephropathy in said patient.
As such, claims 1, 4, 9, 12 are rejected as being prima facie obvious.
Claims 1-12 are rejected under 35 U.S.C. 103 as being unpatentable over Kulkarni et al. (US 2002/0198261, cited in PTO-892) in view of Vissers et al. (J Cancer Surviv 2015, 9, 523-531, cited in PTO-892).
Kulkarni (US 2002/0198261) teaches a method of treating, for example, neuropathic pain [0001], with a composition comprising (Table 1) gabapentin and xylitol.
Kulkarni teaches [0074] that polyhydric alcohols containing 2 to 6 carbon atoms, preferably 3 to 6 carbon atoms, such as, for example, xylitol, can be used as adjuvants for oral liquid gabapentin and pregabalin compositions of the present invention.
Kulkarni teaches administering xylitol in a composition, as pharmaceutical product, as in instant claims 5, 7, 8, 9, to a patient suffering from neuropathic pain, to treat neuropathic pain.
Vissers teaches (pages 524, left column, third paragraph) neuropathic pain in cancer and diabetes patients.
Vissers teaches that, among cancer patients, neuropathic symptoms are often induced by chemotherapeutic agents including taxanes and platinum agents, such as oxaliplatin. Thus, Vissers teaches peripheral neuropathy induced by administration of an anticancer drug, as in instant claim 2, where the anticancer drug is oxaliplatin, a platinum-based anticancer drug, as in instant claim 3.
Vissers teaches that the incidence of chemotherapy-induced peripheral neuropathy is strongly dependent on the type of agent, duration of administration, and dosage used.
Vissers teaches that neuropathy is one of the most common complications of diabetes, with a prevalence around 30 %. Neuropathy is a result of cellular damage caused by oxidative stress and inflammation as a consequence of hyperglycemia and dyslipidaemia in diabetes. The most common presentation is distal symmetrical polyneuropathy characterized by numbness, tingling, pain, or weakness mainly occurring in the feet. Thus, Vissers teaches diabetic peripheral neuropathy, as in instant claim 4.
Vissers also teaches (pages 524, left column, last paragraph) peripheral neuropathy in patients who suffer from diabetes and cancer, as in instant claims 2-4.
It would have been obvious for a person of ordinary skill in the art to combine the teachings of Kulkarni and Vissers to arrive at the instantly claimed invention. The person of ordinary skill in the art would have been administered the composition/pharmaceutical product comprising xylitol taught by Kulkarni, to patients suffering from neuropathic pain, such as cancer patients with chemotherapy-induced neuropathic pain, as in instant claims 2-3, or diabetes patients with diabetic peripheral neuropathy, as in instant claim 4, with the expectation that the composition will be effective to treat neuropathic pain, and the different subtypes of neuropathic pain, in the patients.
Regarding claims 6, 10-12, the person of ordinary skill in the art would have prepared a food product comprising the liquid syrup-based composition of Kulkarni, with the expectation that said composition will retain the therapeutic effect against neuropathic pain.
As such, claims 1-12 are rejected as being prima facie obvious.
Conclusion
Claims 1-12 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to IRINA NEAGU whose telephone number is (571)270-5908. The examiner can normally be reached Mon-Fri 8-5.
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/IRINA NEAGU/Primary Examiner, Art Unit 1629